(32 days)
The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.
The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is a single use monopolar electrosurgical pencil that includes a handpiece with a smoke evacuation function and a range of electrodes (both uncoated and coated). The electrosurgical pencil is compact in size (190 mm long and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and associated electrical cable housed within the tubing. The device is externally powered via an external power generator (supplied by user) connected to a monopolar receptacle using a conventional 3-pin connector. This device remains unchanged from the cleared predicate pencil.
The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is available in two activation switch configurations, a rocker style and push-button style, which activates monopolar cut or coagulate functions operated by pressing the respective button. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume.
Electrodes are available in Blade, Needle, Ball, T-Bar Loop, U-Bar Loop and Conization geometries and are listed in Table 6-1 below
This document details the acceptance criteria and study findings for the Stryker Neptune E-SEP Smoke Evacuation Pencil, a medical device for electrosurgical applications.
The information below is based on the provided 510(k) Summary (K153679).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Area | Acceptance Criteria (Implied by equivalence to predicate and industry standards) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-2 (General requirements for basic safety and essential performance of medical electrical equipment) | Tests demonstrated compliance with IEC 60601-1 and IEC 60601-2-2. |
| Functional / Performance | Deliver intended electrosurgical cutting and coagulation, and effectively evacuate smoke. Consistent performance with predicate device. | Tests demonstrated functionality, integrity, and safety/effectiveness for intended use, supporting substantial equivalence. |
| Thermal Spread | Thermal characteristics consistent with the predicate device and within acceptable safety limits. | Testing was conducted to evaluate thermal spread, and results supported substantial equivalence. (Specific numerical criteria/results not provided beyond a general statement of sufficiency) |
| Biocompatibility | Materials used are biocompatible and do not pose undue risk to patients or users. Compliance with relevant biocompatibility standards. | Biocompatibility testing was performed, and results supported substantial equivalence. |
| Sterilization & Packaging | Device remains sterile, and packaging maintains sterility until point of use. Sterility Assurance Level (SAL) of $10^{-6}$. | Sterilization and packaging testing confirmed sterile single use, EtO sterilization with SAL = $10^{-6}$, and maintained sterility. |
| Mechanical Integrity | Electrodes and pencil maintain structural integrity during use. Suitable for electrosurgical applications. | Testing demonstrated the integrity of the electrodes. (Specific criteria/results not provided beyond a general statement of sufficiency) |
| Material Equivalence | New materials (ABS Plastic, 304 Series Stainless Steel) do not negatively impact safety or performance compared to predicate materials. | Performance testing (including electrical and functional) covered devices with new materials, confirming their suitability. |
| Working Length Equivalence | Longer electrode working lengths (70mm - 165mm) perform comparably to predicate (70mm) in terms of safety and effectiveness. | Performance testing covered various working lengths, supporting similar safety and effectiveness. |
| Geometry Equivalence | New electrode geometries (Needle, Ball, T-Bar Loop, U-Bar Loop, Conization) perform comparably to predicate (Blade, Needle-compatibility) in safety and effectiveness. | Performance testing covered various geometries, supporting similar safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices or tests) for each non-clinical test conducted. It states that "Performance testing was conducted on the proposed devices as determined by the risk analysis for the products."
The data provenance is from non-clinical bench testing performed by the manufacturer, Stryker Instruments. The country of origin for the data is not explicitly stated but is implicitly associated with the manufacturer's testing facilities. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate the performance of the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission relies on non-clinical performance testing (bench testing) rather than studies involving expert interpretation of medical images or diagnostic outcomes. Therefore, there were no experts used to establish ground truth in the traditional sense of clinical or diagnostic studies. The "ground truth" for these engineering and performance tests is defined by established engineering standards (e.g., IEC standards) and the performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
As this was non-clinical bench testing, an adjudication method for a "test set" in the context of expert review or consensus (like 2+1 or 3+1) is not applicable. The outcome of each test was determined by whether the device met the pre-defined engineering and performance specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This submission pertains to a medical device's electrosurgical and smoke evacuation capabilities, and the modifications are extensions of electrodes and material changes. Clinical studies, including MRMC studies, were deemed "not necessary for this 510(k)." The comparison was primarily based on non-clinical performance data and substantial equivalence to the predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This device is an electrosurgical pencil, a physical medical instrument. Therefore, the concept of "standalone (algorithm only without human-in-the loop performance)" as it applies to AI/software devices is not applicable. The performance testing described is inherently for the device itself.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was established by:
- Engineering and Performance Standards: Compliance with recognized international standards such as IEC 60601-1 and IEC 60601-2-2 for electrical safety.
- Predicate Device Performance: The functional, thermal, biocompatibility, and sterilization performance of the legally marketed predicate device (SafeAir Smoke Pencil, K143145) served as the benchmark for substantial equivalence. The proposed device's performance was compared to ensure it was at least as safe and effective.
8. The Sample Size for the Training Set
This medical device is a physical instrument, not an AI or machine learning algorithm. Therefore, the concept of a "training set" in the context of data for model development is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of medical device submission.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.